FDA Device recall Z-1101-2020
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 by Wright Medical Technology, citing two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1101-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-27 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Wright Medical Technology |
| Distribution | n/a |
Product
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Reason
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Identifiers
| code_info | Lot Code 1633010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2020%22
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